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Diagnosing of Acute Tuberculosis (SwEaTB)

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ClinicalTrials.gov Identifier: NCT03667742
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:

Sweat proteins are analysed to investigate differences in protein markers in patients with acute tuberculosis and other pulmonary diseases (pneumonia, Bronchitis, chronic obstructive pulmonary disease (COPD)) and healthy individuals. Differences in sweat protein markers in patients with positive and negative tuberculosis Enzyme-linked-immuno-Spot (EliSpot) are investigated.

Differences in sweat protein markers in the course of treatment in patients receiving tuberculostatic therapy are investigated.


Condition or disease Intervention/treatment
Tuberculosis Diagnostic Test: analysis of sweat and serum samples for protein markers

Study Design
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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SwEaTB - Diagnosing of Acute Tuberculosis
Actual Study Start Date : November 17, 2017
Actual Primary Completion Date : November 4, 2020
Actual Study Completion Date : November 4, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: analysis of sweat and serum samples for protein markers
    collection of blood and sweat samples (with Macroduct Sweat Collecting System) in patients with suspected tuberculosis or proven acute tuberculosis or pulmonary diseases (pneumonia, bronchitis, COPD) and analyzing serum and sweat for protein markers (Early Secretory Antigenic Target (ESAT-6) and Culture Filtrate Protein 10 (CFP-10) and C-reactive protein (CRP) and Amyloid A2 and complement component 1q (C1q)) by mass spectrometry and enzyme-linked immunosorbent assay (ELISA)

Outcome Measures
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Primary Outcome Measures :
  1. Change in protein markers (ESAT-6 and CFP-10 and CRP and Amyloid A2 and C1q) in patients with tuberculosis and other pulmonary diseases [ Time Frame: Sweat samples taken at baseline and 2 weeks after baseline ]
    Distinction of patients with acute tuberculosis from patients with other pulmonary diseases by protein markers (Early Secretory Antigenic Target (ESAT-6) and Culture Filtrate Protein 10 (CFP-10) and C-reactive protein (CRP) and Amyloid A2 and complement component 1q (C1q)). Analysis done by mass spectrometry and enzyme linked immunosorbent assay (ELIZA).

  2. Change in protein markers (ESAT-6 and CFP-10 and CRP and Amyloid A2 and C1q) in patients with tuberculosis and other pulmonary diseases [ Time Frame: Blood samples taken at baseline and 2 weeks after baseline ]
    Distinction of patients with acute tuberculosis from patients with other pulmonary diseases by protein markers (Early Secretory Antigenic Target (ESAT-6) and Culture Filtrate Protein 10 (CFP-10) and C-reactive protein (CRP) and Amyloid A2 and complement component 1q (C1q)). Analysis done by mass spectrometry and enzyme linked immunosorbent assay (ELIZA).


Secondary Outcome Measures :
  1. change of protein markers during tuberculostatic therapy [ Time Frame: sweat and blood sweat and blood samples taken at baseline and 2 weeks after initiating tuberculostatic therapy in patients with active tuberculosis ]
    Analysis of protein markers (Early Secretory Antigenic Target (ESAT-6) and Culture Filtrate Protein 10 (CFP-10) and C-reactive protein (CRP) and Amyloid A2 and complement component 1q (C1q)) during tuberculostatic therapy. Analysis done by mass spectrometry and enzyme linked immunosorbent assay (ELIZA).

  2. Differences in protein markers in patients with other pulmonary diseases [ Time Frame: sweat and blood samples taken at baseline ]
    Analysis and comparison of protein markers (Early Secretory Antigenic Target (ESAT-6) and Culture Filtrate Protein 10 (CFP-10) and C-reactive protein (CRP) and Amyloid A2 and complement component 1q (C1q)) in patients with other pulmonary diseases (pneumonia, Bronchitis, COPD). Analysis done by mass spectrometry and enzyme linked immunosorbent assay (ELIZA).

  3. Differences in protein markers in patients with positive and negative tuberculosis ELISpot [ Time Frame: sweat and blood samples taken at baseline ]
    Analysis and comparison of protein markers (Early Secretory Antigenic Target (ESAT-6) and Culture Filtrate Protein 10 (CFP-10) and C-reactive protein (CRP) and Amyloid A2 and complement component 1q (C1q)) in patients with positive and negative tuberculosis ELISpot. Analysis done by mass spectrometry and enzyme linked immunosorbent assay (ELIZA).


Other Outcome Measures:
  1. detection of tuberculostatic drug in sweat samples in patients with active tuberculosis during tuberculostatic therapy [ Time Frame: sweat samples taken 2 weeks after initiating tuberculostatic therapy in patients with active tuberculosis ]
    Analysis of sweat protein markers in patients with active tuberculosis during tuberculostatic therapy


Biospecimen Retention:   Samples Without DNA
Serum samples, sweat samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
12 In- patients at University Hospital Basel/ Switzerland with acute tuberculosis 16 In- patients at University Hospital Basel/ Switzerland with other pulmonary diseases (Pneumonia, Bronchitis, COPD) 5 Healthy Donors
Criteria

Inclusion Criteria:

  • Adult patients
  • Ability to understand the purpose of the study, provide signed and dated informed consent by patient or his/her legal representative
  • In-patients with acute tuberculosis, suspected tuberculosis or other pulmonary diseases (pneumonia, Bronchitis, COPD)

Inclusion Criteria Healthy Donors:

  • negative for Quantiferon- TB Gold Plus Test or ELISpot

Exclusion Criteria:

  • Initiation of tuberculostatic therapy before baseline
  • Initiation of antibiotic therapy in patients with other pulmonary diseases > 6 hours before baseline
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667742


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4058
Hochschule für Lifescience
Muttenz, Switzerland, 4132
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Jens Eckstein, PD Dr. med Chief Clinical Medical Office
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03667742    
Other Study ID Numbers: 2017-01455; me17Eckstein2
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
sweat protein markers in tuberculosis
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections